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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K874841
Device Name INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
Applicant
Bentley Laboratories, Inc.
17502 Armstrong Ave.
P.O. Box 19522
Irvine,  CA  92713
Applicant Contact MERRITT GIRGIS
Correspondent
Bentley Laboratories, Inc.
17502 Armstrong Ave.
P.O. Box 19522
Irvine,  CA  92713
Correspondent Contact MERRITT GIRGIS
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received11/24/1987
Decision Date 02/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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